Cleared Traditional

K926361 - GLUCOMETER ENCORE QA BLOOD GLUCOSE METER

K926361 is an FDA 510(k) clearance for GLUCOMETER ENCORE QA BLOOD GLUCOSE METER, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K926361 · Heraeus Kulzer, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
185d
Days
Class 2
Risk

K926361 is an FDA 510(k) clearance for the GLUCOMETER ENCORE QA BLOOD GLUCOSE METER. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Mishawaka, US). The FDA issued a Cleared decision on June 24, 1993 after a review of 185 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K926361

510(k) Number K926361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1992
Decision Date June 24, 1993
Days to Decision 185 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 88d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFR Device Classification - Class 2, Special Controls

Product Code CFR Hexokinase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CFR Hexokinase, Glucose

All 138
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K926361.
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION
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K924572 · Em Diagnostic Systems, Inc. · Nov 1992